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Pfizer at-home Covid capsule could possibly be out there by year-end, CEO Albert Bourla says

Pfizer at-home Covid pill could be available by year-end, CEO Albert Bourla says

Pfizer’s experimental oral drug to treat Covid-19 at the first sign of illness could be available by the end of the year, CEO Albert Bourla told CNBC on Tuesday.

The company, which developed the first approved Covid-19 vaccine in the US with the German drug manufacturer BioNTech, started an early clinical study in March testing a new antiviral therapy for Covid. The drug belongs to a class of drugs called protease inhibitors, and it works by blocking an enzyme that the virus needs to replicate in human cells.

Protease inhibitors are used to treat other viral pathogens such as HIV and hepatitis C.

If the clinical trials go well and the Food and Drug Administration approves it, the drug could be distributed in the US by the end of the year, Bourla told CNBC’s Squawk Box.

Health experts say the orally taken drug could be a game changer as people newly infected with the virus could use it outside of hospitals. The researchers hope the drugs will prevent the disease from getting worse and prevent hospital stays.

In addition to the drug, Pfizer is also testing its vaccine in 6-month-old to 11-year-old children. Vaccinating children is critical to ending the pandemic, say public health officials and infectious disease experts.

Earlier this month, the company asked the FDA to extend their vaccine approval to teenagers ages 12-15 after a study found the shot was 100% effective.

Bourla told CNBC on Tuesday that he was “very optimistic” that the FDA would approve the use of the shot in teenagers.

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The C.D.C. and N.I.H. launch a fast, at-home testing initiative in Tennessee and North Carolina.

The C.D.C. and N.I.H. launch a rapid, at-home testing initiative in Tennessee and North Carolina.

The Centers for Disease Control and Prevention and the National Institutes of Health announced a new initiative on Wednesday to see if the frequent and widespread use of rapid coronavirus tests is slowing the spread of the virus.

The program will provide free antigen testing at home to everyone in two communities, Pitt County, NC, and Hamilton County, Tennessee, for free, bringing a total of 160,000 people to test for the coronavirus three times a week for a while a month.

“This is exactly what I and others have been calling for almost a year – widespread, accessible, rapid testing to contain transmission,” said Michael Mina, Harvard University epidemiologist who advocated rapid rapid testing at home programs.

He added, “It’s something anyone can do if they take 30 seconds out of the day three times a week to do the test.”

Antigen tests are cheaper and faster than PCR tests, which are the gold standard for diagnosing Covid-19, the disease caused by the virus. However, they are less sensitive and more prone to false negative results. Mathematical models have shown that if these tests are used frequently, they can still reduce the transmission of the virus.

The tests can help identify people who may not realize they are infectious and cause them to self-isolate before they can transmit the virus to others. Real world data is limited, however, and with virus cases still high across the country, testing is still essential, according to public health experts.

“We have all hypothesized that large-scale home testing could stop the chain of transmission of the virus and allow communities to discover many more cases,” said Bruce Tromberg, who heads the National Institute for Biomedical Imaging and Bioengineering and its rapid acceleration directs the diagnostic program that provides the tests for the initiative. “All mathematical models predict that. But this is an example from the real world, real life. “

Residents who choose to participate in the program can have the tests brought to their home or collect them from local distribution locations. An online tool guides participants through the testing process and helps them interpret their results. Residents can also volunteer to take surveys to see if frequent tests have changed their behavior, knowledge of Covid-19, or their minds about vaccination.

Researchers from the University of North Carolina and Duke University will compare the positivity, case, and hospitalization rates in these two communities with those in other similar communities that are not in the program.

A. David Paltiel, Professor of Health Policy and Management at the Yale School of Public Health, described the start of a real-world study of the effectiveness of rapid home screening as “simply good news.” However, he cautioned that the results need to be interpreted carefully, especially if residents who choose to participate in the initiative are not representative of the entire community.

“We know that self-selection tends to bring out the concerned and a disproportionate number of people who are already Covid-aware or Covid-conscientious,” he said.

“It will be great to see how it works when it’s in the hands of people who really care,” he added. However, he said the results may not be broadly applicable to screening programs that require participation, as may be the case with some workplace and school programs.

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FDA authorizes Abbott’s fast $25 Covid take a look at for at-home use

FDA authorizes Abbott's rapid $25 Covid test for at-home use

Abbott Laboratories BinaxNow kit

Abbott Labs

The Food and Drug Administration announced on Wednesday that it has approved Abbott Labs’ rapid Covid-19 test for home use, despite doctors having to prescribe the test for patients.

The test, which is an antigen test that gives results in about 15 minutes, was previously only approved for trained personnel. With the new release, however, patients can test themselves at home with the virtual support of a doctor. It is the third test approved in the US that “can be used entirely at home,” said Dr. Jeff Shuren, director of the FDA Center for Devices and Radiological Health, in a statement.

Abbott has partnered with telemedicine provider eMed to deliver the test, which is called BinaxNOW and costs $ 25 for home use, at home and oversee the collection and testing process. Patients collect the sample themselves with a nasal swab and an app helps control the testing process and deliver results, Abbott said.

Anyone 15 years or older who is suspected of having Covid-19 by their doctor and who is within the first seven days of symptoms appearing can take the test, according to the FDA. The test can also be used on people 4 years and older, although an adult must collect the sample, the agency said.

“The FDA continues to approve COVID-19 tests, which will give more Americans access to more testing flexibility and options,” said FDA Commissioner Dr. Stephen Hahn in a statement. “The BinaxNOW COVID-19 Ag home test will have a significant manufacturing base and have the potential to support testing for millions of people.”

Abbott expects to run 30 million tests at home in the first quarter of 2021 and another 90 million in the second quarter. The FDA noted that antigen tests are not as accurate as many molecular tests.

“As the pandemic has developed, the need for rapid tests has grown. Unfortunately, we still hear that many people cannot access tests as quickly as they need,” said Robert Ford, Abbott President and CEO, in one Explanation. “That’s why Abbott is bringing our BinaxNOW rapid test and our NAVICA platform home.”

The FDA first approved the test for use by trained personnel in August, touting it as the first Covid-19 test, costing about $ 5 and providing results in minutes on a test card without laboratory equipment, similar to a pregnancy test. The US quickly bought 150 million of the tests for $ 750 million to expand testing capacity.

However, it costs $ 25 to use the test at home, more than what it costs in medical facilities, Abbott said Wednesday.

“The FDA’s approval of the BinaxNOW card test for home use means we should be running tens of millions of COVID-19 tests in the coming months that Americans can use without leaving their homes,” said Alex Azar, Minister of Health and human services, in a statement on Wednesday.

Approval comes after the FDA approved Ellume’s home Covid test on Tuesday. This product has been approved for use on individuals aged 2 years and over and does not require a prescription.